WO2004103431A2 - Protection d'aiguille selective pour aiguilles de seringue - Google Patents

Protection d'aiguille selective pour aiguilles de seringue Download PDF

Info

Publication number
WO2004103431A2
WO2004103431A2 PCT/US2004/015599 US2004015599W WO2004103431A2 WO 2004103431 A2 WO2004103431 A2 WO 2004103431A2 US 2004015599 W US2004015599 W US 2004015599W WO 2004103431 A2 WO2004103431 A2 WO 2004103431A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
shield
shield according
base
effective length
Prior art date
Application number
PCT/US2004/015599
Other languages
English (en)
Other versions
WO2004103431A3 (fr
Inventor
Francesca Dionigi
Original Assignee
Euro 3 S.R.L.
Boshears & Boshears Consulting, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Euro 3 S.R.L., Boshears & Boshears Consulting, Inc. filed Critical Euro 3 S.R.L.
Publication of WO2004103431A2 publication Critical patent/WO2004103431A2/fr
Publication of WO2004103431A3 publication Critical patent/WO2004103431A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • This invention relates generally to devices for injecting medication into a patient and more particularly concerns a needle-shield for hypodermic syringes.
  • the needles used for injections can be of different lengths.
  • the needle length is chosen based on the administration route of the drug to be injected, for example intravascular, intramuscular, subcutaneous or intradermal, and on the patient typology, for example adults or children.
  • the needles currently on the market are sold individually or pre-assembled with the syringes.
  • Some injection devices for example some pens for insulin, have a chill cylindrical element at the needle base that, if rotated before the injection, performs a telescopic motion, hiding a portion of the needle and thus reducing the needle length that penetrates into the patient's skin, as is taught in U.S. Patents Nos. 5,944,700 and 4,841,885.
  • these devices require the assembling of one or more specific elements and generally permit only variations of few millimeters in the needle length. It is, therefore, an object of this invention to provide a needle-shield for hypodennic syringes.
  • a further object of this invention is to provide a needle-shield for hypodermic syringes which enables the user to modify the effective length of the needle to be used.
  • Another object of this invention is to provide a needle-shield for a hypodermic syringe which can be modified in its length by simply removing the whole needle-shield or by removing only its upper part, thus selecting a well defined portion of the needle for penetration of the patient's skin.
  • Yet another object of this invention is to provide a needle-shield for a hypodermic syringe which allows the user to exactly decide, for the same needle, in function of its needs, the length to use for the injection.
  • Still a further object of this invention is to provide a needle-shield for a hypodermic syringe such that the user need not replace a needle pre-assembled on a syringe when a different needle length is required. It is also an object of this invention to provide a needle-shield for a hypodermic syringe which reduces handling of the syringe needle before use and, consequently, the risk of contamination. Moreover, it is an object of this invention to provide a needle-shield for hypodermic needle which can be used in every field and for syringes pre-filled with drugs, where the use of different needle lengths ix permitted, such as for pediatric use or for drugs that may be administrated by more than one route.
  • a needle-shield for a needle of a hypodermic syringe has upper and lower parts with a breaking point therebetween so that the upper part of the needle-shield may be removed to reduce the effective length of the needle to a shorter predetermined length.
  • the upper and lower parts may be unitary with the breaking point being a thin-walled section of the unitary structure.
  • the upper and lower parts may be distinct and preassembled at a predetermined point.
  • the distinct parts may be of different materials, for example the upper part of bromo-butylic rubber and the lower part of polypropylene.
  • the lower part may also have at least three flexible radial flaps blocking the lower part to a luer to which the needle is fixed.
  • Protrusions may be provided on a surface of the shield to facilitate rotation of the upper part with respect to the lower part to separate the upper part from the lower part.
  • the needle-shield may have a base shaped to be fitted into an activation head of an activable hypodennic injection device.
  • the shield base may have flaps that, during activation of the device, fit into guides in the activation head to prevent the base from rotating with respect to the activation head.
  • the shield may be made of rigid transparent plastic, such as polypropylene, so- as to render the effective length of the needle visible to users.
  • indicia on the lower part of the shield may identify a longer selectable effective length of the needle when the upper and lower parts are removed and a shorter selectable effective length of the needle when only the upper part is removed.
  • Figure 1 is a perspective view of a first configuration of the needle-shield, assembled to a hypodermic syringe
  • Figure 2 is a cross-sectional view of the needle-shield of Figure 1;
  • Figure 3 is a perspective view of the syringe of Figure 1 with the needle-shield completely removed to permit use of the whole length of the needle;
  • Figure 4 is a perspective view of the syringe of Figure 1 with only the upper part of the needle-shield removed to permit use with a shorter effective length of the needle;
  • Figure 5 is a cross-sectional view of a second configuration of the needle-shield assembled to a pre-filled syringe
  • Figure 6 is a front view of the base element of the needle-shield of Figure 5;
  • Figure 7 is a bottom view of the element of Figure 6;
  • Figure 8 is a side view of the syringe of Figure 5 with only the upper part of the needle-shield removed to permit use with a shorter effective length of the needle;
  • Figure 9 is a side view of the syringe of Figure 5 with the needle-shield completely removed to pennit use of the whole length of the needle;
  • Figure 10 is a perspective view of a third configuration of the needle-shield assembled to an activable hypodermic injection device
  • Figure 11 is a perspective view of the injection device of Figure 10 after activation
  • Figure 12 is a perspective view of the activated device of Figure 11 with the needle-shield completely removed to permit use of the whole length of the needle; and Figure 13 is a perspective view of the activated device of Figure 11 with only the upper part of the needle-shield removed to permit use of a shorter effective length of the needle.
  • the needle-shield 1 constituted by a single element, preferably of plastic such as polypropylene, may have a tubular or conical shape and is closed at one end 11 and open at its base. Looking at Figure 2, at a determined distance from the base, a breaking point 17 is provided at which the thickness of the plastic wall is sensibly thinner.
  • the base of the needle-shield 1 is similar to those of normal plastic needle-shields and fits the hub 22 of the needle 24 with similar mechanisms.
  • the needle-shield 1 has on its base a flange or a ring 12 of greater thickness that acts as a grip in the operations of capping the needle 24 with the needle-shield 1 and removal of the whole needle-shield 1 or removal of only its upper part 18 if the user wants to reduce the effective length of the needle 24.
  • Two flaps 15 and 16 on the needle-shield 1 provide the user with a stable grip to rotate the upper part 18 with respect to the base 19 and, consequently, to break the needle-shield 1 at the break point 17. Looking at Figure 3, to use the needle 24 at its maximum length, the user must remove the needle-shield 1 handling it from the grip 12, as performed with conventional needle-shields.
  • the needle-shield 1 can recap the syringe to protect the needle 24 before the syringe is wasted into a suitable wasting container.
  • the effective length of the needle 24 being the length of the needle that will penetrate into the patient
  • the user keeping the grip 12 of the base 19 of the needle-shield 1 blocked with two fingers, will rotate the upper part 18 of the needle-shield with the other hand, causing its rupture at the break point 17.
  • the base 19 will remain attached to the hub 22 of the needle 24.
  • the needle-shield in all of its preferred configurations, may be transparent so as to allow the user to see the needle 24.
  • the needle-shield may indicate, by color or by a printing of indicia such as numbers on its external surface, the effective lengths permitted by the needle 24, that is the whole length and the reduced length.
  • the needle- shield is constituted by two elements, made of the same material or of different materials and assembled at a point 17a.
  • butylic rubber may be used for the upper part 18a and polypropylene for the base 19a.
  • This configuration of the needle-shield can be applied, for example, to a pre-filled syringe 2a, for which an hermetic closure of the needle tip is needed to preserve the stability of the drug during storage. If the user wants to use the syringe 2a with the shorter effective length of the needle 24, it is sufficient that only the rubber element 18a is removed, keeping the plastic element 19a on the luer 25 of the syringes 2a, as is seen in Figure 8.
  • the base 19a has a tronco-conical part 193, seen in Figure 6, which is made to fit the rubber element 18a.
  • the system to block the needle-shield to the luer 25 of the syringe 2a consists of three or more flexible radial flaps 192, seen in Figure 5 and Figure 7, or in a simple sealing ring.
  • the flaps 191 also stabilize the position of the base 19a, as they put it in contact with the needle 24.
  • the special needle- shield of this invention replaces the needle-shield of an activable hypodermic injection device 3b like the device submitted on July 15, 2002 in Italian Application No. RM2002A000278, and can be activated by pushing the grip 12 of the needle-shield lb against the activation head 3.
  • the needle-shield lb has a narrower base 13 that fits into the guide 31 of the activation head 3. After activation of the device, the flaps 20 on the external surface of the base 13 slide into the guides 311 on the internal surface of the activation head 31 port.
  • the guides 311 block the flaps 20 on the base of the needle-shield lb and, consequently, block the component 19b, making easier the rupture of the needle- shield at the break point 17. For this reason, for this configuration, it is not necessary that the user keeps the base element 19b of the needle-shield lb blocked with the fingers when the upper part 18 is rotated to remove it.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une protection d aiguille pour seringues hypodermiques qui possède un point de cassure (17) et une forme qui permet de facilement retirer soit toute la protection d'aiguille (1) soit uniquement sa partie supérieure (18). Dans ce dernier cas, la partie inférieure (18) reste à la base de l'aiguille, ce qui réduit sa longueur efficace, celle-ci étant la longueur de la partie qui pénétrera dans l'anatomie du patient.
PCT/US2004/015599 2003-05-19 2004-05-19 Protection d'aiguille selective pour aiguilles de seringue WO2004103431A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITRM2003A000241 2003-05-19
IT000241A ITRM20030241A1 (it) 2003-05-19 2003-05-19 Involucro copri-ago selettivo per aghi di siringhe.

Publications (2)

Publication Number Publication Date
WO2004103431A2 true WO2004103431A2 (fr) 2004-12-02
WO2004103431A3 WO2004103431A3 (fr) 2005-02-10

Family

ID=29765820

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/015599 WO2004103431A2 (fr) 2003-05-19 2004-05-19 Protection d'aiguille selective pour aiguilles de seringue

Country Status (2)

Country Link
IT (1) ITRM20030241A1 (fr)
WO (1) WO2004103431A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009097634A1 (fr) * 2008-02-07 2009-08-13 Brigitte Pickhard Seringue d'injection
AT512978A1 (de) * 2012-06-08 2013-12-15 Hagl Peter Dipl Ing Abdeckkappe, Messgerät mit Abdeckkappe und Verfahren zur Herstellung einer Abdeckkappe
EP2829295A1 (fr) * 2013-07-24 2015-01-28 Raumedic Ag Dispositif d'injection médicale
US9339600B2 (en) 2006-01-10 2016-05-17 Salvus Technology Limited Safety needle
EP3597246A4 (fr) * 2017-09-27 2020-05-27 Volkov, Daniil Vasilievitch Complexe de perfectionnement de seringue

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5395319A (en) * 1991-03-06 1995-03-07 Suddeutsche Feinmechanik Gmbh Needle for inserting an object into the body
WO1996003171A1 (fr) * 1994-07-22 1996-02-08 Epimed Kunststofftechnik Gesmbh Tete de seringue

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5395319A (en) * 1991-03-06 1995-03-07 Suddeutsche Feinmechanik Gmbh Needle for inserting an object into the body
WO1996003171A1 (fr) * 1994-07-22 1996-02-08 Epimed Kunststofftechnik Gesmbh Tete de seringue

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9339600B2 (en) 2006-01-10 2016-05-17 Salvus Technology Limited Safety needle
EP1971382B1 (fr) * 2006-01-10 2016-09-07 Salvus Technology Limited Aiguille de sûreté
WO2009097634A1 (fr) * 2008-02-07 2009-08-13 Brigitte Pickhard Seringue d'injection
US8728042B2 (en) 2008-02-07 2014-05-20 Pharma Consult Ges.M.B.H. Injection syringe
AT512978A1 (de) * 2012-06-08 2013-12-15 Hagl Peter Dipl Ing Abdeckkappe, Messgerät mit Abdeckkappe und Verfahren zur Herstellung einer Abdeckkappe
AT512978B1 (de) * 2012-06-08 2015-10-15 Hagl Peter Dipl Ing Abdeckkappe, Messgerät mit Abdeckkappe und Verfahren zur Herstellung einer Abdeckkappe
US9739665B2 (en) 2012-06-08 2017-08-22 Vasema Diagnostics Ag Covering cap and measuring device
EP2829295A1 (fr) * 2013-07-24 2015-01-28 Raumedic Ag Dispositif d'injection médicale
US10279122B2 (en) 2013-07-24 2019-05-07 Raumedic Ag Medical injection device
EP3597246A4 (fr) * 2017-09-27 2020-05-27 Volkov, Daniil Vasilievitch Complexe de perfectionnement de seringue

Also Published As

Publication number Publication date
ITRM20030241A1 (it) 2004-11-20
WO2004103431A3 (fr) 2005-02-10
ITRM20030241A0 (it) 2003-05-19

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